The PCORnet Tools for e-consent workgroup on the PCORnet Commons is a collaborative space fostering innovation among those who are currently implementing or seeking to develop tools and strategies for obtaining electronic informed consent. This active group is open to all who are interested in seeking input on electronic informed consent tools under development, resources, and lessons learned. To facilitate the sharing of ideas, the workgroup is hosting a two-part webinar series this Fall. The first webinar will include presentations from those with real-world experience with implementing electronic consent within PCORnet. This is an opportunity to interact with colleagues and learn about the innovative work being done in electronic consent.

Speakers

Holly Robertson is a Project Leader in the Global Outcomes MegaTrials group at Duke Clinical Research Institute (DCRI) with over 15 years of experience in pre-clinical and clinical research. Prior to joining DCRI, Dr. Robertson obtained her PhD in Pharmacology from the University of Colorado Health Sciences Center in Denver, CO and completed her post-doctoral work at Duke University in the Neurobiology Department. She then spent several years managing a large research team in the McGovern Institute for Brain Research at Massachusetts Institute of Technology (MIT) with appointments at the Broad Institute and the Stanley Center for Psychiatric Research. She currently leads the PCORI-funded ADAPTABLE Study which is the first study to enroll patients using the PCORnet infrastructure of CDRN, PPRN, and HPRN networks. She leads a multi-disciplinary team which collaborates across participating partners to design and implement large pragmatic clinical studies, focusing on the use of innovative techniques including e-consent and integration of trial activities within healthcare systems. She is passionate about patient-centered research and the building of collaborative communities of patients, researchers, and clinicians to improve the design and execution of clinical studies to improve quality of care.

Thomas Carton is the Chief Development Officer for the Louisiana Public Health Institute and Principal Investigator of REACHnet, a PCORI-funded Clinical Data Research Network. He leads a multi-institutional and multi-disciplinary team that is creating a regional informatics, patient engagement, and research infrastructure to efficiently conduct pragmatic clinical trials nested within the healthcare delivery system. He serves on the PCORnet Research Committee, where he leads a research innovations workgroup that explores and disseminates advances in research efficiency, co-coordinates research efforts across 11 Collaborative Research Groups, and co-leads the Public Health Research Interest Group. He is a member of an Agency for Healthcare Research and Quality (AHRQ) Technical Expert Panel outlining competencies for the next generation of Learning Health System (LHS) researchers. Additionally, he is an Adjunct Professor in the Department of Global Health Management and Policy at the Tulane University School of Public Health and Tropical Medicine, where he teaches doctoral-level courses in introductory and intermediate econometrics and advises doctoral students.

Colleen Lawrence, PhD, CCRP is a Manger of Translational Research at the Vanderbilt Institute for Clinical and Translational Research (VICTR)/Research Support Services and a project manager with the national Trial Innovation Network. Colleen is responsible for managing several national committees including the CTSA Workforce Development Domain Task Force (DTF) and the Trial Innovation Network Standard Agreements & Streamlined Budgeting Working Group. Colleen specializes in building tools to support the research enterprise. Her current projects include building a REDCap-based model for electronic consent, managing the preparation and REDCap implementation of an Umbrella Confidential Disclosure Agreement (CDA) for the Trial Innovation Network, and building a REDCap-based Intern/Student/Observer Customized Action Plan (used to help mentors/mentees to know and document their research, safety, and regulatory obligations before beginning a research experience at Vanderbilt).

Madelaine Faulkner is the Project Director for the Health eHeart Alliance, a PCORI funded Patient Powered Research Network, at the University of California San Francisco. The Alliance is a multi-stakeholder network comprised of researchers, patients, advocacy organizations and physicians with the goal of designing mechanisms that allow patients to get involved in research that matters to them. She directs funded, patient-initiated research projects in collaboration with other PCORI networks including leading the patient advisory board for ADAPTABLE. She also serves as a leader for the Cardiovascular Health Collaborative Research Group, which seeks to catalyze high impact CVH research that utilizes PCORnet infrastructure. She has expertise leveraging technology to design, implement and evaluate research initiatives, feedback mechanisms, and result dissemination loops.

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